Perceptions of control and unrealistic optimism in early-phase cancer trials

2017 ◽  
Vol 44 (2) ◽  
pp. 121-127 ◽  
Author(s):  
Lynn A Jansen ◽  
Daruka Mahadevan ◽  
Paul S Appelbaum ◽  
William M P Klein ◽  
Neil D Weinstein ◽  
...  
Keyword(s):  
Early Phase ◽  
Multivariate Regression ◽  
Mental Image ◽  
Multivariate Regression Analysis ◽  
Trial Participation ◽  
Unrealistic Optimism ◽  
Effective Interventions ◽  
Oncology Trial ◽  
Strong Correlate ◽  
The Usa

PurposeRecent research has found unrealistic optimism (UO) among patient-subjects in early-phase oncology trials. Our aim was to investigate the cognitive and motivational factors that evoke this bias in this context. We expected perceptions of control to be a strong correlate of unrealistic optimism.MethodsA study of patient-subjects enrolled in early-phase oncology trials was conducted at two sites in the USA. Respondents completed questionnaires designed to assess unrealistic optimism and several risk attribute variables that have been found to evoke the bias in other contexts.ResultsOne hundred and seventy-one patient-subjects agreed to be interviewed for our study. Significant levels of perceived controllability were found with respect to all nine research-related questions. Perceptions of control were found to predict unrealistic optimism. Two other risk attribute variables, awareness of indicators (p=0.024) and mental image (p=0.022), were correlated with unrealistic optimism. However, in multivariate regression analysis, awareness and mental image dropped out of the model and perceived controllability was the only factor independently associated with unrealistic optimism (p<0.0001).ConclusionPatient-subjects reported that they can, at least partially, control the benefits they receive from participating in an early-phase oncology trial. This sense of control may underlie unrealistic optimism about benefiting personally from trial participation. Effective interventions to counteract unrealistic optimism may need to address the psychological factors that give rise to distorted risk/benefit processing.

Informed consent for early-phase clinical trials: therapeutic misestimation, unrealistic optimism and appreciation

2019 ◽  
Vol 45 (6) ◽  
pp. 384-387 ◽  
Author(s):  
Jodi Halpern ◽  
David Paolo ◽  
Andrew Huang
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Early Phase ◽  
Phase 1 ◽  
Trial Participation ◽  
Unrealistic Optimism ◽  
Personal Significance ◽  
Decision Making Capacity ◽  
Early Phase Clinical Trials ◽  
Motivation To Participate

Unrealistic therapeutic beliefs are very common—the majority of patient-subjects (up to 94%) enrol in phase 1 trials seeking and expecting significant medical benefit, even though the likelihood of such benefit has historically proven very low. The high prevalence of therapeutic misestimation and unrealistic optimism in particular has stimulated debate about whether unrealistic therapeutic beliefs in early-phase clinical trials preclude adequate informed consent. We seek here to help resolve this controversy by showing that a crucial determination of when such therapeutic beliefs are ethically problematic turns on whether they are causally linked and instrumental to the motivation to participate in the trial. Thus, in practice, it is ethically incumbent on researchers to determine which understanding and beliefs lead to the participant’s primary motivation for enrolling, not to simply assess understanding, beliefs and motivations independently. We further contend that assessing patient-subjects’ appreciation as a component of informed consent—it is already an established component of decision-making capacity assessments—can help elucidate the link between understanding-beliefs and motivation; appreciation refers to an individual’s understanding of the personal significance of both the medical facts and the experience of trial participation. Therefore, we recommend that: (1) in addition to the usual question, ‘Why do you want to participate in this trial?’, all potential participants should be asked the question: ‘What are you giving up by participating in this trial?’ and (2) researchers should consider the settings in which it may be possible and practical to obtain ‘two-point consent’.

scholarly journals Racial disparities in knowledge, attitudes and practices related to COVID-19 in the USA

2020 ◽  
Vol 42 (3) ◽  
pp. 470-478 ◽  
Author(s):  
Wilson M Alobuia ◽  
Nathan P Dalva-Baird ◽  
Joseph D Forrester ◽  
Eran Bendavid ◽  
Jay Bhattacharya ◽  
...  
Keyword(s):  
Racial Disparities ◽  
Sex Education ◽  
Multivariate Regression ◽  
Multivariate Regression Analysis ◽  
Kaiser Family Foundation ◽  
Attitudes And Practices ◽  
Health Insurance Status ◽  
The Usa ◽  
Novel Coronavirus ◽  
Knowledge Attitudes And Practices

Abstract Background Recent reports indicate racial disparities in the rates of infection and mortality from the 2019 novel coronavirus (coronavirus disease 2019 [COVID-19]). The aim of this study was to determine whether disparities exist in the levels of knowledge, attitudes and practices (KAPs) related to COVID-19. Methods We analyzed data from 1216 adults in the March 2020 Kaiser Family Foundation ‘Coronavirus Poll’, to determine levels of KAPs across different groups. Univariate and multivariate regression analysis was used to identify predictors of KAPs. Results In contrast to White respondents, Non-White respondents were more likely to have low knowledge (58% versus 30%; P &lt; 0.001) and low attitude scores (52% versus 27%; P &lt; 0.001), but high practice scores (81% versus 59%; P &lt; 0.001). By multivariate regression, White race (odds ratio [OR] 3.06; 95% confidence interval [CI]: 1.70–5.50), higher level of education (OR 1.80; 95% CI: 1.46–2.23) and higher income (OR 2.06; 95% CI: 1.58–2.70) were associated with high knowledge of COVID-19. Race, sex, education, income, health insurance status and political views were all associated with KAPs. Conclusions Racial and socioeconomic disparity exists in the levels of KAPs related to COVID-19. More work is needed to identify educational tools that tailor to specific racial and socioeconomic groups.

scholarly journals 1574. Multivariate Regression Analysis to Determine Independent Predictors of Treatment Outcomes in the RESTORE-IMI 2 Trial

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S785-S786
Author(s):  
Robert Tipping ◽  
Jiejun Du ◽  
Maria C Losada ◽  
Michelle L Brown ◽  
Katherine Young ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Clinical Response ◽  
Treatment Outcomes ◽  
Multivariate Regression ◽  
Multivariate Regression Analysis ◽  
Apache Ii Score ◽  
Double Blind ◽  
Mitt Population ◽  
Study Results ◽  
All Cause Mortality

Abstract Background In the RESTORE-IMI 2 trial, imipenem/cilastatin/relebactam (IMI/REL) was non-inferior to PIP/TAZ for treating hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP) in the primary endpoint of Day 28 all-cause mortality (D28 ACM) and the key secondary endpoint of clinical response (CR) at early follow-up (EFU; 7-14 d after end of therapy). We performed a multivariate regression analysis to determine independent predictors of treatment outcomes in this trial. Methods Randomized, controlled, double-blind, phase 3, non-inferiority trial comparing IMI/REL 500 mg/250 mg vs PIP/TAZ 4 g/500 mg, every 6 h for 7-14 d, in adult patients (pts) with HABP/VABP. Stepwise-selection logistic regression modeling was used to determine independent predictors of D28 ACM and favorable CR at EFU, in the MITT population (randomized pts with ≥1 dose of study drug, except pts with only gram-positive cocci at baseline). Baseline variables (n=19) were pre-selected as candidates for inclusion (Table 1), based on clinical relevance. Variables were added to the model if significant (p &lt; 0.05) and removed if their significance was reduced (p &gt; 0.1) by addition of other variables. Results Baseline variables that met criteria for significant independent predictors of D28 ACM and CR at EFU in the final selected regression model are in Fig 1 and Fig 2, respectively. As expected, APACHE II score, renal impairment, elderly age, and mechanical ventilation were significant predictors for both outcomes. Bacteremia and P. aeruginosa as a causative pathogen were predictors of unfavorable CR, but not of D28 ACM. Geographic region and the hospital service unit a patient was admitted to were found to be significant predictors, likely explained by their collinearity with other variables. Treatment allocation (IMI/REL vs PIP/TAZ) was not a significant predictor for ACM or CR; this was not unexpected, since the trial showed non-inferiority of the two HABP/VABP therapies. No interactions between the significant predictors and treatment arm were observed. Conclusion This analysis validated known predictors for mortality and clinical outcomes in pts with HABP/VABP and supports the main study results by showing no interactions between predictors and treatment arm. Table 1. Candidate baseline variables pre-selected for inclusion Figure 1. Independent predictors of greater Day 28 all-cause mortality (MITT population; N=531) Figure 2. Independent predictors of favorable clinical response at EFU (MITT population; N=531) Disclosures Robert Tipping, MS, Merck & Co., Inc. (Employee, Shareholder) Jiejun Du, PhD, Merck & Co., Inc. (Employee, Shareholder) Maria C. Losada, BA, Merck & Co., Inc. (Employee, Shareholder) Michelle L. Brown, BS, Merck & Co., Inc. (Employee, Shareholder) Katherine Young, MS, Merck & Co., Inc. (Employee, Shareholder)Merck & Co., Inc. (Employee, Shareholder) Joan R. Butterton, MD, Merck & Co., Inc. (Employee, Shareholder) Amanda Paschke, MD MSCE, Merck & Co., Inc. (Employee, Shareholder) Luke F. Chen, MBBS MPH MBA FRACP FSHEA FIDSA, Merck & Co., Inc. (Employee, Shareholder)Merck & Co., Inc. (Employee, Shareholder)

Epicardial fat thickness as arterial hypertension predictor in normotensive patients with abdominal obesity

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Kuznetsova ◽  
M Druzhilov
Keyword(s):  
Blood Pressure ◽  
Regression Analysis ◽  
Blood Glucose ◽  
Waist Circumference ◽  
Arterial Hypertension ◽  
Multivariate Regression ◽  
Fasting Blood Glucose ◽  
Multivariate Regression Analysis ◽  
Epicardial Fat Thickness ◽  
Fat Thickness

Abstract Objective Arterial hypertension (HTN) is one of the most common diseases associated with obesity. Visceral obesity (VO) with dysfunctional visceral adipose tissue plays the main role in obesity induced HTN. Direct criteria of VO including echocardiographic epicardial fat thickness (EFT) may become an additional predictor of HTN. Purpose The aim was to assess the role of echocardiographic EFT (EEFT) as a predictor of HTN in normotensive patients with abdominal obesity (AO). Methods 526 normotensive men (according to ambulatory blood pressure monitoring (ABPM) without therapy) with AO (waist circumference (WC) &gt;94 cm) and SCORE &lt;5%, without cardiovascular diseases and diabetes mellitus were examined (age 45.1±5.0 years). The lipid and glucose profiles, creatinine, uric acid and C-reactive protein blood levels, albuminuria evaluation, echocardiography, carotid ultrasound, bifunctional ABPM were performed. The values of EEFT ≥75 percentile for persons 35–45 years and 46–55 years were 4.8 mm and 5.8 mm respectively. These values used as epicardial VO criteria. Patients with subclinical carotid atherosclerosis due to the lipid-lowering therapy administration (n=98) were excluded from the follow-up. Re-examination with ABPM was conducted on average through 46.3±5.1 months. Data were summarized as mean ± standard error, statistical analysis conducted with paired two-tailed t-tests, Pearson χ2 criterion and multivariate regression analysis. Results Data of 406 persons were available for analysis. HTN as average daily blood pressure ≥130/80 mm Hg was detected in 157 (38.7%) patients. These patients were characterized by initially higher values of age (45.9±4.6 years vs 44.3±4.9 years, p&lt;0.001), waist circumference (106.9±7.3 cm vs 104.2±7.3 cm, p&lt;0.001), body mass index (BMI) (32.0±3.3 kg/m2 vs 30.9±3.2 kg/m2, p&lt;0.001), average daily systolic and diastolic blood pressure (120.7/74.5±4.6/3.4 mm Hg vs 118.2/73.2±5.5/3.9 mm Hg, p&lt;0.001), EEFT (5.2±0.7 mm vs 4.4±1.0 mm, p&lt;0.001). The epicardial VO was initially detected in 95 (23.3%) patients. In patients with HTN the initial prevalence of epicardial VO was greater (58.0% vs 23.3%, p&lt;0.001). As predictors for the multivariate regression analysis the clinical and laboratory examinations data and EEFT were evaluated. According to the results a mathematical model for estimating the probability HTN was obtained: 0.696*fasting blood glucose + 0.198*systolic BP + 2.844*EFT – 40.166 (constant). Among these predictors EEFT was characterized by the highest standardized regression coefficient (0.302, p&lt;0.001) (0.295, p&lt;0.01 for fasting blood glucose, 0.035, p&lt;0.001 for systolic BP). The Hosmer-Lemeshow test value was 0.863, the total percentage of correct classifications was 86%, the area under the ROC-curve was 0.913. Conclusions EEFT (4.8 mm for persons 35–45 years and 5.8 mm for persons 46–55 years) may be an additional predictor of HTN in normotensive patients with AO. Funding Acknowledgement Type of funding source: None

Arterial stiffness could reflect increased cardiac load and reduced pulmonary function in the general population

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Murai ◽  
T Sugiura ◽  
Y Dohi ◽  
H Takase ◽  
T Mizoguchi ◽  
...  
Keyword(s):  
Regression Analysis ◽  
General Population ◽  
Arterial Stiffness ◽  
Pulmonary Function ◽  
Multivariate Regression ◽  
Troponin I ◽  
Augmentation Index ◽  
Smoking Status ◽  
Multivariate Regression Analysis ◽  
The Other

Abstract Background Pulmonary function is known to decrease with age and reduced pulmonary function has been reported to be associated with all-cause mortality and cardiovascular death. The association between pulmonary impairment and atherosclerosis was reported previously but has not been investigated sufficiently in the general population. Purpose We hypothesized that arterial stiffness could reflect increase of cardiac load and reduced pulmonary function. The present study aimed to investigate whether increased cardiac load and reduced pulmonary function could affect arterial stiffness in the general population. Methods Subjects undergoing their health check-up were enrolled. Plasma B-type natriuretic peptide (BNP) levels and serum high-sensitivity cardiac troponin I (hs-cTnI) levels were measured to evaluate cardiac load and myocardial damage. Radial augmentation index (rAI) was measured to investigate arterial stiffness using HEM-9000AI device. Subjects with an ST-T segment abnormality on the electrocardiogram, renal insufficiency, cancer, active inflammatory disease, or a history of cardiovascular events and pulmonary disease were excluded. Pulmonary function was assessed using spirometry by calculating forced vital capacity (FVC) as a percentage of predicted value (FVC%-predicted), forced expiratory volume in 1 second (FEV1) as a percentage of predicted value (FEV1%-predicted), and the ratio of FEV1 to FVC (FEV1/FVC). Results A total of 1100 subjects aged 57 years were enrolled and their median values of BNP and hs-cTnI were 15.5 and 2.3 pg/ml. The levels of rAI were significantly associated with the levels of BNP after adjustment for possible confounders in multivariate regression analysis, but were not with the levels of hs-TnI. While the parameters of pulmonary function were inversely associated with the levels of rAI and hs-cTnI after adjustment for possible confounders in the multivariate regression analysis, but not with the levels of BNP. The other multivariate regression analyses where BNP, hs-cTnI, parameters of pulmonary function, and the other possible factors were simultaneously included as independent variables revealed that the BNP levels and the FVC%-predicted or FEV1%-predicted, besides age, gender, smoking status, body mass index, blood pressure, heart rate, creatinine, fasting plasma glucose, and triglyceride, were significantly associated with the levels of rAI. Conclusions The significant associations of rAI with BNP and pulmonary function were revealed in the general population. These findings support that arterial stiffness could reflect increased cardiac load and reduced pulmonary function, in apparently healthy individuals. Funding Acknowledgement Type of funding source: None

Serum adipokines in patients with psoriatic arthritis and psoriasis alone and their correlation with disease activity

2012 ◽  
Vol 72 (12) ◽  
pp. 1956-1961 ◽  
Author(s):  
Lihi Eder ◽  
Jai Jayakar ◽  
Remy Pollock ◽  
Fawnda Pellett ◽  
Arane Thavaneswaran ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Multivariate Regression ◽  
Statistical Significance ◽  
Joint Inflammation ◽  
Severity Index ◽  
Serum Levels ◽  
Multivariate Regression Analysis ◽  
Model Assessment ◽  
Continuous Variables ◽  
Factor Α

ObjectiveTo compare the prevalence of metabolic syndrome (MetS) and the levels of related biomarkers in patients with psoriatic arthritis (PsA) and psoriasis without arthritis (PsC).MethodsThis study compared patients with PsA and patients with PsC. The presence of MetS was determined. Serum levels of insulin, adiponectin and leptin were measured. The homeostasis model assessment for insulin resistance (HOMA-IR) was calculated. HOMA-IR, adiponectin and leptin were log-transformed. Continuous variables were compared using the t test and the χ2 test was used for discrete variables. Multivariate regression models were used to investigate the association of MetS and adiponectin with PsA compared to PsC after adjusting for potential confounding variables.Results203 PsA and 155 PsC patients were analysed. The prevalence of MetS was higher in PsA patients compared to those with PsC. However, this did not reach statistical significance (36.5% vs 27.1%, p=0.056). The levels of adipokines were significantly higher in PsA compared to PsC: adiponectin (8.8±5.2 vs 7.4±4.5 log (µg/ml), p=0.009) and leptin in women (3.1±0.8 vs 2.8±0.8, log (ng/ml), p=0.04). HOMA-IR was also higher in PsA (0.97±0.63 vs 0.68±0.81, p<0.001). No difference was observed in leptin levels in men. In multivariate regression analysis, PsA (p=0.04) and the psoriasis area and severity index score (p=0.02) were associated with MetS. Adiponectin was significantly associated with PsA (p=0.005), the use of anti-tumour necrosis factor α therapy (p=0.03) and active joint count (p=0.001).ConclusionsMetS and related adipokines correlated with an increased burden of skin and joint inflammation.

Sign in / Sign up

Export Citation Format

Share Document